Using kava to help people quit smoking and manage stress and sleep issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates how well active smokers comply with a daily kava regimen while intending to quit smoking. It investigates whether kava can aid in tobacco cessation, alleviate stress, and enhance sleep quality during the quitting process. Participants will be given either kava or a placebo to assess the effects of kava on their smoking cessation journey. The study aims to provide insights into the holistic benefits of kava in managing withdrawal symptoms associated with quitting smoking.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* adults aged 21 years or above (legal age for smoking in the U.S.) up to 75 years old;
* self-reported smoking at least 5 cigarettes/day for the past year with INTENTION to quit at time of screening visit;
* expired carbon monoxide level of more than 8 ppm at recruitment;
* willingness to participate in the proposed study, as indicated by signed informed consent;
* access to a functional telephone;
* expected presence in the study's geographical area for the next 4 months;
* not currently enrolled in any smoking cessation programs per self report; and
* female subjects of childbearing potential will be required to practice acceptable methods of birth control (the acceptable methods of birth control include birth control pills, Birth Control Shot, Birth Control Implant, IUD, Diaphragm, and cervical cap).
* if a participant takes kava dietary supplement, a 2-week washout period is needed for the participant to initiate this study or if a participant participated in a kava trial before, such as the kava JEK trial, the participant could be enrolled if the inclusion criteria above are met, including the 2-week washout period.

Exclusion Criteria:

* history of active cancer (other than non-melanoma skin cancer) within the past 2 years;
* diagnosed with liver dysfunction or with previous liver diseases;
* levels of alanine transaminase, aspartate transaminase, alkaline phosphatase or total bilirubin over limit of normal (ULN) range at prescreen;
* inability to refrain from acetaminophen, alcohol (no more than one drink daily via self-report), or other potentially hepatotoxic substances;
* are pregnant or nursing (lactating) or of childbearing age planning to become pregnant or unwilling to use adequate contraception during the study;
* participant answered "Yes" to any of the Modified Ask Suicide Screening Questions questions 1 through 3, or refuses to answer all of the questions. If subject answers 'Yes' to question 4 but the most recent suicide attempt took place \>12 months from screening visit then subject is still eligible.

Where it's running

• University of Florida
  Gainesville, Florida, United States Recruiting

Study contacts

• Principal investigator: Ramzi Salloum, PhD — University of Florida
• Study coordinator: Ramzi G Dr. Salloum
• Email: rsalloum@ufl.edu
• Phone: 352-294-4997

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.